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GMDP Expert Gids

Farmaceutische freelancers met expertise in GMP, GDP en compliance — afgestemd op uw project.

Specialisatie

Competenties

Distribution & Supply

Cold chain / temperature-controlled logistics GDP (Good Distribution Practice)

IT / CSV

Computer System Validation Data Integrity

Logistics & Distribution

Cold Chain Management GDP Compliance

Manufacturing Types

Controlled substances / narcotics Highly potent / cytotoxic Inhalation & nasal Liquid & semi-solid Oral solid dosage Packaging Sterile manufacturing Transdermal

Product Types

API Manufacturing ATMP Biologics & biosimilars Medical devices & combination products Plasma-derived medicinal products Radiopharmaceuticals Vaccines Veterinary pharmaceuticals

Quality Assurance

Annual Product Quality Review Batch Release CAPA Management Change Control Deviation Management Internal auditing Regulatory inspection support SOP Writing & Review Supplier Auditing

Quality Control

Analytical testing Biological & Immunological Testing Microbiological testing Out-of-Specification (OOS) Investigation Stability Study Design & Execution

Quality

Batch Release CAPA Management Change Control Deviation Management GMP Auditing SOP Writing & Review

Regulatory Affairs

Pharmacovigilance Pharmacovigilance QPPV Regulatory Submissions Regulatory Submissions

Validation

Cleaning Validation Cleaning validation Computer system validation Equipment qualification Facility qualification IQ/OQ/PQ Validation Method validation Process Validation Process validation

Certificering

QP Humaan QP Vet GDP ISO Six Sigma ADR Prevention Environment

Regio

Actieve filters: Analytical testing × Alles wissen

GMDP-0066

Quality Control / Quality Assurance Professional

Beschikbaar

Quality Control

QC/QA professional with 6 years in cGMP-regulated pharma and biologics. Specialises in deviation management, root cause analysis, CAPA, OOS investigat...

5 jaar erv. South Holland , Nederland

Deviation Management Gevorderd Out-of-Specification (OOS) Investigation Gevorderd Microbiological testing Gevorderd Biological & Immunological Testing Gevorderd +12 meer

Sterility Test and Rapid Microbiological Method for Pharmaceuticals Chemical and Biological Spill Compendial HPLC Practices +2 meer

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GMDP-0053

Pharmacienne / Chargée de Mission Qualité , Recherche clinique &Affaires Réglementaires

Beschikbaar

GMP & GDP

Docteur en Pharmacie avec expertise en assurance qualité, affaires réglementaires , Export pharmaceutique,recherche clinique et économie de la santé. ...

7 jaar erv. Indre-et-Loire (Centre-Val de Loire) , Frankrijk

CAPA Management Gevorderd Out-of-Specification (OOS) Investigation Gevorderd Deviation Management Gevorderd IQ/OQ/PQ Validation Gevorderd +7 meer

Formation en Marketing Pharmaceutiques Formation en Digital Marketing Formation sur BPF (Bonnes Pratiques de Fabrication) +1 meer

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GMDP-0091

Senior CSV Validation Consultant

Beschikbaar

Computer System Validation

Senior CSV Validation Consultant with 9+ years in pharmaceutical, biotech and GMP manufacturing. Expert in GAMP 5, Annex 11, 21 CFR Part 11, IQ/OQ/PQ,...

15 jaar erv. Verenigd Koninkrijk

Computer system validation Expert Data Integrity Expert IQ/OQ/PQ Validation Expert Equipment qualification Gevorderd +8 meer

ECA Computer Validation Course – Introduction to Risk Management and the GAMP 5 Approach

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GMDP-0041

Operations & Quality Performance Specialist

Beschikbaar

GMP & GDP

Operations and quality professional with hands-on experience across pharmaceutical manufacturing and GSP-compliant warehousing. Background spans quali...

4 jaar erv. Accra , Ghana

GDP Compliance Gevorderd GDP (Good Distribution Practice) Gevorderd SOP Writing & Review Gevorderd Internal auditing Gemiddeld +5 meer

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GMDP-0036

VP – MSAT & Head of Manufacturing

Beschikbaar

Manufacturing / Production

Biopharmaceutical leader with 28+ years of global experience in end-to-end vaccine manufacturing, specializing in drug substance (DS) production, tec...

28 jaar erv. Masaki, Dar Es Salam, Tanzania , Tanzania

Vaccines Expert Biologics & biosimilars Expert Sterile manufacturing Expert CAPA Management Gevorderd +22 meer

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GMDP-0088

EU GDP Responsible Person / Regulatory Affairs Officer / Pharmacovigilance Manager / CSV Expert / Medical Device Registered Person

Beschikbaar

GMP & GDP

EU Registered Pharmacist with 10+ years in Quality Assurance, Regulatory Compliance, GDP/GMP, CSV (Annex 11/GAMP 5), pharmacovigilance, and medical de...

11 jaar erv. Zebbug , Malta

Computer system validation Expert GDP Compliance Expert GDP (Good Distribution Practice) Expert Internal auditing Gevorderd +20 meer

EU GDP Responsible Person Medical Device Registered Person (MDR) Pharmacovigilance Manager / LCQPPV / EUQPPV +1 meer

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GMDP-0046

Independant Consultant - Oral Solid Dose Expert & Global Operations Leader

Beschikbaar

Process Engineering

A highly motivated graduate with in excess of 25 years’ technical and global operations management experience in Oral Solid Dose, Sterile and Sterile ...

27 jaar erv. Remote , Ierland

Process validation Expert Oral solid dosage Expert Liquid & semi-solid Expert Deviation Management Gevorderd +18 meer

RAPS Dual Certification – Regulatory Affairs Lean Six Sigma Green Belt BJCP Certified Beer Judge +2 meer

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GMDP-0076

Senior Validation / CQV Engineer

Beschikbaar

Validation / Qualification

Senior CQV, Validation & Quality professional with 10+ years in pharma/biotech. Expert in IQ/OQ/PQ, CSV, process validation, cleanroom qualification, ...

10 jaar erv. Texas , Verenigde Staten

Process validation Expert IQ/OQ/PQ Validation Expert Computer system validation Expert Regulatory inspection support Gevorderd +13 meer

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GMDP-0007

Qualified Person

Beschikbaar voor deeltijd

Qualified Person (QP)

Passionate Qualified Person with a heart for Quality. Deep knowledge of batch release, QA, auditing and QC.

11 jaar erv. Antwerp , België

GMP Auditing Expert Batch Release Expert SOP Writing & Review Expert Facility qualification Gevorderd +14 meer

GDP ISO QP Vet +1 meer

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GMDP-0028

Director Quality Assurance / Quality Control

Beschikbaar voor deeltijd

Quality Assurance

QA/QC Director with 30+ years in pharma. Expert in external quality assurance, GMP compliance, deviation/CAPA management, Lean manufacturing, and regu...

31 jaar erv. North Holland , Nederland

CAPA Management Expert Deviation Management Expert Change Control Expert Data Integrity Gevorderd +13 meer

GMP Training Lean Manufacturing Quality Management +2 meer

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